A Post-Market Assessment of the Safety and Performance of the TriClip™ System

TREAT TR is a prospective, observational, single-arm, multi-center, post-market study designed to confirm the safety and performance of the TriClip System in a contemporary, real-world setting in accordance with its approved indications for use. The study will be conducted at up to 100 centers globally. Clinical investigation assessments will be conducted prior to the procedure to assess eligibility. Follow-up visits after the TriClip procedure will occur at discharge, 30 days, 6 months (telephone), 12 months, and annually through 5-years. An independent echocardiographic core laboratory (ECL) will be utilized for evaluating echocardiograms. An imaging substudy will be conducted at a subset of participating sites in up to 250 subjects who consent to participate in the substudy. Cardiac-gated computed tomography (CT) will be performed at baseline and 12 months to evaluate reverse cardiac remodeling.

• Tricuspid Transcatheter Edge-to-Edge Repair (TEER) (Device): TriClip System

Primary outcomes

• Rate of Peri-Procedural Adverse Events [Through 30 days post-procedure]: Defined as all-cause mortality, device embolization, device thrombosis, non-elective surgery or transcatheter intervention for device- or procedure-related adverse event (AE) new pacemaker implantation and device- or procedure related major bleeding
• Tricuspid Regurgitation (TR) grade less than or equal to moderate [At 30-day follow-up]
• Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score improvement of at least 10 points [At 30-day follow-up]: All KCCQ scores are scaled from 0 (worst) to 100 (best possible status), where the higher score reflects a better health status.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Subject is eligible to receive the TriClip System per the current approved indications for use and is intended to undergo the procedure.
2. Subject, or their legally authorized representative, has provided written informed consent prior to study procedure.
3. Subject agrees to attend follow-up assessments.
4. Subject is ≥ 18 years of age (or legal age of consent) at time of consent.

Exclusion Criteria:

1. Subject is participating in another clinical study that could impact the follow-up or results of this study.
2. Subject has an existing TriClip implant
3. Presence of other conditions or factors that, in the Investigator's opinion, could limit the subject's ability to participate in follow-up.

• Meghan Griffin, Study director, Abbott